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Oral Midazolam Vs Oral Promethazine Premedication Effect on Dental Sedation

A Clinical Trial to Compare Oral Midazolam and Oral Promethazine Effect as Premedication on Sedation among Uncooperative Children undergoing dental procedures

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016120516106N3
Enrollment
26
Registered
2017-10-29
Start date
2013-12-31
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental anxiety and management. Mental and behavioural disorders

Interventions

Intervention 1: Intervention group 1 :In 1st session oral Midazolam suspension premedication (0.5mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg). Then in
Treatment - Drugs
Intervention group 1 :In 1st session oral Midazolam suspension premedication (0.5mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg). Then in 2nd session ora
Intervention group 2 : In 1st session oral Promethazine suspension premedication (0.5mg/kg) is administered half an hour before IV Ketamin (2mg/kg) and IV Midazolam (0.5 mg/kg). Then in 2nd sessi

Sponsors

Vice Chancellor of Research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: uncooperative children aged 2-6 years; completely negative Frankle behavioral scale; ASA I or II for systemic health; two teeth requiring the same treatment in two separate sessions Exclusion Criteria: any systemic disease with contraindication for sedation or premedication ;nasal obstruction;respiratory infection; mouth opening limitation; macroglossia; tonsillar hypertrophy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Patient's Cooperation for Sedation. Timepoint: At the IV Administration step. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Nausea and vomitting. Timepoint: After the end of treatment and sedation. Method of measurement: Questionair.;Sleeepiness. Timepoint: After the end of treatment and sedation. Method of measurement: Questionair.;Dizziness. Timepoint: After the end of treatment and sedation. Method of measurement: Questionair.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfshin Zarghi

Shahid Beheshti University of Medical Sciences

zarghi@sbmu.ac.ir+98 21 2243 9780

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026